ColoScreen 551565

Trade name

ColoScreen

Generic name

Faecal occult blood IVD, kit, rapid colorimetric, clinical

Model / reference

551565

Primary DI / UDI-DI

M5255515650

FDA product code

KHE

GMDN term

Faecal occult blood IVD, kit, rapid colorimetric, clinical

Device class

Class II

Regulation number

864.6550

GUDID distribution status

In Commercial Distribution

Category: Faecal occult blood IVD, kit, rapid colorimetric, clinical

Other devices filed under FDA product code KHE (REAGENT, OCCULT BLOOD).

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• DBEST OCCULT BLOOD TEST KIT by Ameritek, Inc.
• IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10 by Ind Diagnostic, Inc.
• FLEXSURE OBT by Smithkline Diagnostics, Inc.
• EASE-A-CULT by Diagnostica, Inc.
• IMMUNOCCULT EIA TEST KIT by Intl. Immunoassay Laboratories, Inc.
• HEMOCCULT-C by Menley & James Laboratories
• FLEET DETECTATEST by C.B. Fleet Co., Inc.
• OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT by Sekisui Diagnostics, LLC
• OCCULT BLOOD TEST by Breit Laboratories, Inc.

• V8 AFSA2 Hemo Control 1812

  Class II

  FDA 510(k) K192931 Active Cleared 19 Apr 2022 GUDID on market

• V8 Nexus Hemoglobin UltraScreen 1828

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  FDA 510(k) K192931 Active Cleared 19 Apr 2022 GUDID on market

• A1AT Controls 3435

  Class I

  FDA 510(k) K213396 Active Cleared 13 Oct 2022 GUDID on market

• SPIFE A1AT Kit 552651

  Class II

  FDA 510(k) K213396 Active Cleared 13 Oct 2022 GUDID on market

See all devices from Helena Laboratories, Corp. →